(E)-4-(2-(Aminomethyl)-3-fluoroallyloxy)-N-tert-butylbenzamide is an amine oxidase, copper containing 3 (AOC3) inhibitor, which is known from WO 2013/163675 (compound 23). Its synthesis and uses thereof are also described in said International Application.
As a precondition for a broadly based use of (E)-4-(2-(aminomethyl)-3-fluoroallyloxy)-N-tert-butylbenzamide and its pharmaceutically acceptable salts in the treatment of the above-mentioned diseases and conditions, a pharmaceutical composition and/or a pharmaceutical dosage form comprising said active ingredients that fulfills the usual criteria needs to be provided. The usual criteria for pharmaceutical compositions include i.a. a good and reproducible bioavailability of the active ingredient, an acceptable form and size, an acceptable shelf-life and a good storage stability, i.e. a low degradation of the active ingredient over time. E.g., one of the acceptance criteria for degradation is a total degradation of not more than 3.0% total degradation after a storage of 36 months, preferably, the total degradation is not more than 1.5% after 36 months of storage or even lower.
Presently, there is an unmet medical need for methods, medicaments and pharmaceutical compositions with a good efficacy with regard to fibrotic diseases, metabolic diseases and ocular diseases, for example non-alcoholic fatty liver (NAFL) disease, non-alcoholic steatohepatitis (NASH) or diabetic retinopathy, while at the same time complying with the standard criteria for pharmaceutical compositions and dosage forms.